MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM

Model Number 384466

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2023

Event Type  malfunction  

Event Description

Date of insertion (b)(6) 2023.¿during change of shift oncoming and leaving rn did bedside safety check.Picc line was assessed and noticed leaking of lipids, other iv fluid and blood on blanket.Both rns assess the hub of the picc line and saw a crack in the red port.Red port was infusing lipids, a heparin patency, and had a medline attached.The red port was then clamped.The blue lumen had milrinone, morphine, precedex, vecuronium, and tpn infusing.¿ ¿harm not significant, placement of multiple piv and piccs¿.

Manufacturer Narrative

The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.

Event Description

¿date of insertion (b)(6) 2023¿ ¿during change of shift oncoming and leaving rn did bedside safety check.Picc line was assessed and noticed leaking of lipids, other iv fluid and blood on blanket.Both rns assess the hub of the picc line and saw a crack in the red port.Red port was infusing lipids, a heparin patency, and had a medline attached.The red port was then clamped.The blue lumen had milrinone, morphine, precedex, vecuronium, and tpn infusing.¿ ¿harm not significant, placement of multiple piv and piccs¿.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.Even though a tracking label was provided, at this time, there has been no sample returned for a review.Without a sample to review, the investigation of the reported issues is not possible.Since the reported issue could not be investigated with a returned sample, determining a definite root cause and corrective action is not possible.If the sample is returned a future date, this complaint will reopened at that time for evaluation.

• Brand Name: L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM
• Type of Device: L-CATH PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 16903977
• MDR Text Key: 314925020
• Report Number: 0001625425-2023-01049
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384466
• Device Catalogue Number: 384466
• Device Lot Number: 11469774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other